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NCT05593614

Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10% and 15% w/w) in Comparison to Placebo, in Cancer Survivor Adult Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)
AlgoTherapeutix·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chemotherapy-induced Peripheral Neuropathy
Drug/Device/Intervention
ATX01 10%
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AlgoTherapeutix
Location
Clermont,Bethesda,Prague,Paris,Suresnes,Konin,Tychy,Barcelona,Madrid,Terrassa, Czech,France,Poland,Spain,United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Jan 01, 2023
End date
Dec 31, 2023
Enrollment
240 participants
Primary outcome

Change from baseline to Week 12 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.

Summary

The purpose of this clinical trial is to compare the efficacy of twice daily applications of
 ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating
 chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.

ICD-10 classifications
Drug-induced polyneuropathyParaneoplastic neuromyopathy and neuropathyPolyneuropathy due to other toxic agentsIdiopathic peripheral autonomic neuropathyIdiopathic progressive neuropathy
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05593614
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05593614 through Pure Global AI's free database. This Phase 2 trial is sponsored by AlgoTherapeutix and is currently Recruiting. The study focuses on Chemotherapy-induced Peripheral Neuropathy. Target enrollment is 240 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.